Condition or disease | Intervention/treatment | Phase |
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Diabetic Neuropathies | Other: Physical therapy by foot-ankle segmental and functional exercises | Not Applicable |
A randomized controlled trial will be performed with 62 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group that will perform exercises at home, three times a week, through the SOPeD (Diabetic Foot Guidance System) software for 12-weeks. The exercise program is customized during the performance by a perceived effort scale reported by the participant.
The subjects will be evaluated in 3 different times to access the effect of the intervention: baseline and 12 weeks, for all outcomes; and 24 weeks, for follow-up reasons for all outcomes. The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms and signs by Michigan Neuropathy Screening Instrument, (2) fuzzy score of the neuropathy severity, (3) foot-ankle kinematics during gait (infrared cameras) (4) foot-ankle joint moment during gait (infrared cameras and force plate), (5) plantar pressure distribution during gait, (6) tactile (monofilaments), (7) vibration sensitivity (tuning fork), (8) foot health and functionality by the Foot Health Status Questionnaire, (9) Foot isometric strength (pressure plate measurement), (10) functional balance reach test.
The hypothesis of this study is that the intervention will increase the perception of the tactile and vibratory sensitivity of the foot, reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, increase the functional balance score, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, promote a more physiological foot rollover with a redistribution of plantar pressure during gait, as well as increase foot-ankle mobility after 12-weeks of intervention. There will be also beneficial biomechanical changes during gait, such as: (1) increase in the ankle extensor moment and ankle concentric power in the propulsion phase and (3) increase in the ankle flexor moment and ankle eccentric power in the load phase.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 62 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Masking Description: | Single |
Primary Purpose: | Treatment |
Official Title: | Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-I) Randomized Controlled Trial |
Actual Study Start Date : | August 1, 2019 |
Estimated Primary Completion Date : | July 1, 2021 |
Estimated Study Completion Date : | March 1, 2022 |
Arm | Intervention/treatment |
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Experimental: Intervention Group
Patients in the intervention group will perform foot-related exercises described in the SOPeD software three times/week at home via web-software. In the follow-up period, patients will follow the same schedule set by the project till the end of the study.
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Other: Physical therapy by foot-ankle segmental and functional exercises
The physiotherapeutic foot-ankle exercise protocol is based on previous clinical trials. It was designed following three criteria established in a supervised, face-to-face intervention: muscle stretching; strengthening of the intrinsic muscles; and strengthening of the extrinsic foot-ankle muscles and functional exercises, such as balance and gait training. To avoid monotony, game principles were inserted to reward the exercise execution and enhance motivation. The exercises change from session to session, and the maximum duration is no longer than 20 minutes. The exercises should only be done 3 times/week; no more than eight exercises each day; and the individual difficulty is regulated by the effort scale to manage the customized progression. In total, 39 different exercises were chosen, and when including their sublevels of progression, a total of 104 different exercises can be completed.
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No Intervention: Control Group
Participants in the control group will not receive any specific intervention in addition to the treatment recommended by the health professionals team (doctors, nurses, podiatrists), which includes pharmacological treatment, and self-care recommendations and foot care by international consensus.
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Isabel de Camargo Neves Sacco, PhD | +551130918426 | icnsacco@usp.br | |
Contact: Jane Suelen Silva Pires Ferreira, Ms | +5511982879811 | janesuelen@yahoo.com.br |
Brazil | |
Universidade de São Paulo | Recruiting |
São Paulo, Brazil, 05360-160 | |
Contact: Jane Suelen Silva Pires Ferreira, MS +5511982879811 janesuelen@yahoo.com.br | |
Contact: Ronaldo Henrique Cruvinel Júnior +5511987706975 ronaldocruvinelfisioterapia@gmail.com |
Principal Investigator: | Isabel de Camargo Neves Sacco, PhD | Associate Professor at São Paulo University |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 11, 2019 | ||||||||
First Posted Date ICMJE | July 8, 2019 | ||||||||
Last Update Posted Date | November 5, 2020 | ||||||||
Actual Study Start Date ICMJE | August 1, 2019 | ||||||||
Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment in People With Diabetic Neuropathy | ||||||||
Official Title ICMJE | Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-I) Randomized Controlled Trial | ||||||||
Brief Summary | The main objective of this trial is to investigate the effect of a customized foot-related exercises software (SOPeD) in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy. | ||||||||
Detailed Description |
A randomized controlled trial will be performed with 62 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group that will perform exercises at home, three times a week, through the SOPeD (Diabetic Foot Guidance System) software for 12-weeks. The exercise program is customized during the performance by a perceived effort scale reported by the participant. The subjects will be evaluated in 3 different times to access the effect of the intervention: baseline and 12 weeks, for all outcomes; and 24 weeks, for follow-up reasons for all outcomes. The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms and signs by Michigan Neuropathy Screening Instrument, (2) fuzzy score of the neuropathy severity, (3) foot-ankle kinematics during gait (infrared cameras) (4) foot-ankle joint moment during gait (infrared cameras and force plate), (5) plantar pressure distribution during gait, (6) tactile (monofilaments), (7) vibration sensitivity (tuning fork), (8) foot health and functionality by the Foot Health Status Questionnaire, (9) Foot isometric strength (pressure plate measurement), (10) functional balance reach test. The hypothesis of this study is that the intervention will increase the perception of the tactile and vibratory sensitivity of the foot, reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, increase the functional balance score, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, promote a more physiological foot rollover with a redistribution of plantar pressure during gait, as well as increase foot-ankle mobility after 12-weeks of intervention. There will be also beneficial biomechanical changes during gait, such as: (1) increase in the ankle extensor moment and ankle concentric power in the propulsion phase and (3) increase in the ankle flexor moment and ankle eccentric power in the load phase. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Assignment Masking: Double (Investigator, Outcomes Assessor)Masking Description: Single Primary Purpose: Treatment
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Condition ICMJE | Diabetic Neuropathies | ||||||||
Intervention ICMJE | Other: Physical therapy by foot-ankle segmental and functional exercises
The physiotherapeutic foot-ankle exercise protocol is based on previous clinical trials. It was designed following three criteria established in a supervised, face-to-face intervention: muscle stretching; strengthening of the intrinsic muscles; and strengthening of the extrinsic foot-ankle muscles and functional exercises, such as balance and gait training. To avoid monotony, game principles were inserted to reward the exercise execution and enhance motivation. The exercises change from session to session, and the maximum duration is no longer than 20 minutes. The exercises should only be done 3 times/week; no more than eight exercises each day; and the individual difficulty is regulated by the effort scale to manage the customized progression. In total, 39 different exercises were chosen, and when including their sublevels of progression, a total of 104 different exercises can be completed.
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
62 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | March 1, 2022 | ||||||||
Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Brazil | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04011267 | ||||||||
Other Study ID Numbers ICMJE | FOCA-I | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Isabel de Camargo Neves Sacco, University of Sao Paulo General Hospital | ||||||||
Study Sponsor ICMJE | University of Sao Paulo General Hospital | ||||||||
Collaborators ICMJE | Conselho Nacional de Desenvolvimento Científico e Tecnológico | ||||||||
Investigators ICMJE |
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PRS Account | University of Sao Paulo General Hospital | ||||||||
Verification Date | November 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |